EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX

May 5, 2023 updated by: SynCore Biotechnology Co., Ltd.

A Randomized Controlled, Open Label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1+GEM vs GEM Alone in Patients With Measurable Locally Advanced/Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment

The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of the study was to assess the safety and efficacy of a combination therapy of EndoTAG-1 plus gemcitabine vs. gemcitabine monotherapy in patients with locally advanced and/or metastatic adenocarcinoma of the pancreas eligible for second-line therapy after failing first line therapy with FOLFIRINOX

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
218

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • CHU Angers
      • Besançon, France
        • CHRU - Besançon
      • Bordeaux, France
        • Hopital Haut Lévêque
      • Brest, France
        • CHRU Brest - Hopital Morvan
      • Cholet, France
        • Centre Hospitalier de Cholet
      • Dijon, France
        • Centre Georges François Leclerc
      • La Roche-sur-Yon, France
        • Centre Hospitalier Departemental
      • Lyon, France
        • Hopital Prive Jean Mermoz
      • Marseille, France
        • La Timone
      • Nancy, France
        • Institut de Cancerologie de Lorraine
      • Nice, France
        • Centre Antoine-Lacassagne
      • Paris, France
        • Hôpital La Pitié Salpêtrière
      • Perpignan, France, 66046
        • CH Saint Jean
      • Rennes, France
        • Centre Eugène Marquis
      • Strasbourg, France
        • Clinique Sainte Anne/Strasbourg Oncologie Leberale
  • Hungary
      • Budapest, Hungary
        • Magyar Honvedseg Egeszsegugyi Kozpont
      • Budapest, Hungary
        • Orszagos Onkologiai Intezet
      • Budapest, Hungary
        • Dél-pesti Centrumkórház - Országos Hematológia és Infektológia Intézet
      • Kecskemét, Hungary
        • Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont
      • Miskolc, Hungary
        • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
      • Pécs, Hungary
        • Pécsi Tudomány Egyetem Onkoterápiás Intézet
  • Israel
      • Hadera, Israel
        • Oncology Department, Hillel Yafe MC
      • Haifa, Israel
        • Rambam Health Center
      • Kfar Sava, Israel
        • Meir Medical Center
      • Petach Tikva, Israel
        • Rabin MC
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
  • Korea, Republic of
      • Daejeon, Korea, Republic of
        • Chungnam National University Hospital
      • Goyang-si, Korea, Republic of
        • National Cancer Center
      • Incheon-si, Korea, Republic of
        • Inha University Hospital
      • Jeongnam, Korea, Republic of
        • Chonnam National University Hwasun Hospital
      • Seongnam, Korea, Republic of
        • CHA Bundang Medical Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital
      • Suwon, Korea, Republic of
        • Ajou University Hospital
  • Russian Federation
      • Arkhangel'sk, Russian Federation
        • Arkhangelsk Clinical Oncological Dispensary
      • Kursk, Russian Federation
        • Kursk State Clinical Oncology Dispensary
      • Moscow, Russian Federation
        • Federal State Budgetary Scientific Institution "Russian Oncological Scientific Center named after N.N.Blokhin"
      • Moscow, Russian Federation
        • Private clinnic "Medicine 24/7"
      • Omsk, Russian Federation
        • Budget Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary"
      • Orenburg, Russian Federation
        • State Budget Healthcare Institution "Orenburg Region Clinical Oncological Dispensary"
      • Saint Petersburg, Russian Federation
        • State Budgetary Healthcare Institution Leningrad Regional Oncology Center
  • Taiwan
      • Changhua, Taiwan
        • Changhua Christian Hospital
      • Kaohsiung, Taiwan
        • E-Da Hospital
      • Kaohsiung, Taiwan
        • Chang Gung Medical Foundation - Kaohsiung Branch
      • Taichung, Taiwan
        • China Medical University Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Taipei, Taiwan
        • Tri-Service General Hospital (TSGH)
      • Taipei, Taiwan
        • Mackay Memorial Hospital-Taipei branch
      • Taoyuan, Taiwan
        • Chang Gung Medical Foundation - Linkou Branch
  • United States
    • California
      • Corona, California, United States, 92879
        • Compassionate Cancer Care Medical Group, Inc
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Columbus, Georgia, United States, 31904
        • John B. Amos Cancer Center / IACT Health
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Orchard Healthcare Research (OHR) Inc.
    • Indiana
      • Indianapolis, Indiana, United States, 46260-2082
        • Investigator Clinical Research Centers of Indiana
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Hematology & Oncology Associates, Ltd.
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Cancer Center (SNCC) - Central Clinic - Main Clinic
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840-1625
        • Guthrie - Corning Hospital - Guthrie Cancer Center
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Charleston Cancer Center
    • Texas
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders
      • Temple, Texas, United States, 76508
        • Scott & White Vasicek Cancer Treatment Center
      • The Woodlands, Texas, United States, 77380
        • Renovatioclinical
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University Of Virginia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Written informed consent
  3. Histologically or cytologically confirmed adenocarcinoma of the pancreas
  4. Metastatic or locally advanced disease that is considered unresectable
  5. Measurable / assessable disease according to RECIST v.1.1
  6. Documented disease progression on first line FOLFIRINOX
  7. Negative pregnancy test
  8. Both male and female patients and their partners of childbearing potential must agree to use two medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or one of the following methods of birth control (intrauterine devices, tubal sterilization or vasectomy) or must practice complete abstinence from intercourse of reproductive potential during the course of the study and for 90 days after last treatment (excluding women who are not of childbearing potential and men who have been sterilized).
  9. ECOG performance status 0 or 1

Exclusion Criteria:

  1. Cardiovascular disease, New York Heart Association (NYHA) III or IV
  2. History of severe supraventricular or ventricular arrhythmia
  3. History of coagulation or bleeding disorder
  4. History of acute myocardial infarction within 6 months before randomization
  5. History of congestive heart failure
  6. Acute or chronic inflammation (autoimmune or infectious)
  7. Significant active/unstable non-malignant disease likely to interfere with study assessments

  8. Laboratory tests (hematology, chemistry) outside specified limits:

    1. WBC ≤ 3 x 10³/mm³
    2. ANC ≤ 1.5 x 10³/mm³
    3. Platelets ≤ 100.000/mm³
    4. Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
    5. aPTT > 1.5 x ULN
    6. Serum creatinine > 2.0 mg/dl (> 176.8 μmol/l)
    7. AST and/or ALT > 2.5 x ULN; for patients with significant liver metastasis AST and/or ALT > 5 x ULN
    8. Alkaline phosphatase > 2.5 x ULN
    9. Total bilirubin > 2 x ULN
    10. Albumin < 2.5 g/dL
  9. Clinically significant ascites
  10. Any anti-tumor treatment (except FOLFIRINOX as the first-line therapy) for pancreatic adenocarcinoma before enrollment. Note: Patients who have undergone surgical interventions for pancreatic adenocarcinoma will be eligible.
  11. Any radiotherapy for pancreatic adenocarcinoma before enrollment except for treatment of bone metastases if target lesions are not included in the irradiated field
  12. Major surgery < 4 weeks prior to enrollment
  13. Pregnant or nursing
  14. Investigational medicinal product < 4 weeks of enrollment
  15. Documented HIV history
  16. Active hepatitis B infection requiring acute therapy Note: Subjects infected by the hepatitis B virus will be eligible for the study if they have no signs of hepatic decompensation and meet the liver function tests eligibility criteria.
  17. Known hypersensitivity to any component of the EndoTAG-1 and/or gemcitabine formulations
  18. History of malignancy other than pancreatic cancer < 3 years prior to enrollment, except nonmelanoma skin cancer or carcinoma in situ of the cervix treated locally
  19. Vulnerable populations (e.g. subjects unable to understand and give voluntary informed consent)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EndoTAG-1 and Gemcitabine
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Drug: EndoTAG-1
twice weekly
Other Names:
  • EndoTAG-1 was first developed by Munich Biotech AG (Germany) under the names LipoPac and MBT-0206 and by Medigene AG under the name of EndoTAG-1.
Drug: Gemcitabine
once weekly
Other Names:
  • Gemcitabine Hydrochloride
Active Comparator: Gemcitabine Monotherapy
Gemcitabine 1000mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Drug: Gemcitabine
once weekly
Other Names:
  • Gemcitabine Hydrochloride

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From randomization to death from any cause or last day known to be alive, up to approximately 33.5 months (assessed continuously during treatment)
The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning subject death, compared to number of subjects censored at the time of analysis.
From randomization to death from any cause or last day known to be alive, up to approximately 33.5 months (assessed continuously during treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From randomization to either first observation of progressive disease or occurrence of death, up to approximately 33.5 months (assessed continuously during treatment)
The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning first observation of progressive disease, compared to number of subjects censored at the time of analysis.
From randomization to either first observation of progressive disease or occurrence of death, up to approximately 33.5 months (assessed continuously during treatment)
Percentage of Subjects With Objective Response
Time Frame: Up to approximately 33.5 months (assessed continuously during treatment)
Percentage of subjects with objective response is based on assessment of complete response (CR) or partial response (PR) according to RECIST v.1.1.
Up to approximately 33.5 months (assessed continuously during treatment)
Duration of Response
Time Frame: From the first documentation of objective tumor response (date of the first CR or PR) to objective tumor progression or death due to any cause.
Duration of Response = (date of tumor progression or death - date of first objective response (CR or PR) +1) / 30.
From the first documentation of objective tumor response (date of the first CR or PR) to objective tumor progression or death due to any cause.
Percentage of Subjects With Disease Control According to RECIST v.1.1
Time Frame: Up to approximately 33.5 months (assessed continuously during treatment)
Percentage of subjects with disease control is based on assessment of complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST v.1.1
Up to approximately 33.5 months (assessed continuously during treatment)
Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate
Time Frame: Up to approximately 33.5 months (assessed at baseline, end of cycle 1 or the full treatment course)
Responders are defined as subjects with a reduction in CA 19-9 levels by least 50% from baseline to the end of cycle 1 (or end of full treatment course). If a subject died while on study, he/she was classified as a failure, regardless of previous assessments.
Up to approximately 33.5 months (assessed at baseline, end of cycle 1 or the full treatment course)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
Time Frame: Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT))
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowled habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.
Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT))
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Time Frame: Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT))
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30): included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/ vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score = better level of functioning or greater degree of symptoms. Change from baseline = Cycle/day score minus baseline score.
Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT))

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SynCore Biotechnology Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Li-Tzong Chen, M.D., Ph.D., National Cheng Kung University Hospital,Tainan, Taiwan, R.O.C

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT4006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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